Effect of Mulberry Leaf Extract on Blood Glucose

Prediabetic State Clinical Trial

Official title:

Effect of Mulberry Leaf Extract on Blood Glucose in Subjects With Impaired Fasting Glucose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01385865
• Other study ID #: MLE_Biofood_2
• Status: Completed
• Phase: N/A
• First received: June 28, 2011
• Last updated: October 27, 2011
• Start date: January 2011
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: Ewha Womans University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of mulberry leaf extract on blood glucose in subjects with impaired fasting glucose.

Description:

The purpose of this study is to evaluate the effect of mulberry leaf extract on blood glucose in subjects with impaired fasting glucose. After 2 weeks run-in period for wash-out, subjects will randomly assigned to two groups, i.e. control group (placebo) or mulberry leaf extract group. They will intake placebo or mulberry leaf extract for 4 weeks. Biomarkers will be analyzed in blood samples in 0 and 4 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Age: over 20 years

• Fasting glucose: 100mg/dl = ~ = 125mg/dl

• HbA1c: < 6.5%

Exclusion Criteria:

• Subject who has taken medicines, Chinese medicines and Health/Functional Foods which can affect glucose metabolism in 30 days prior to screening visit

• Subject who has taken part in other clinical trials in 30 days prior to screening visit

• Subject who is pregnant or breast feeding

• Subject who lost body weight over 4 kg in 30 days prior to screening visit

• Alcoholic

• Heavy smoker (= 20 cigarettes/day)

• Subject who has heart failure, coronary artery disease, uncontrolled hypertension (= 140/90mmHg), diabetes (fasting blood glucose = 126mg/dL), renal dysfunction, liver failure, hyperthyroidism, hypothyroidism, cancer or mental disease

• Subject who has an allergy to the ingredients of study product

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Prediabetic State

Intervention

Dietary Supplement:
• Mulberry leaf extract
18 tablets/day (6 tablets/serving x 3servings/day, mulberry leaf extract 336mg/1 tablet (800mg), 1-Deoxynojirimycin 4.3mg/1 g mulberry leaf extract), Duration: 4 weeks
• Placebo
18 tablets/day (6 tablets/serving x 3servings/day, lactose 511mg/1 tablet (650mg)), Duration: 4 weeks

Locations

Country	Name	City	State
Korea, Republic of	Bundang CHA Medical Center	Seongnam	Gyeonggi-Do

Sponsors (3)

Lead Sponsor	Collaborator
Ewha Womans University	CHA University, Ministry of Knowledge Economy, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose change with meal tolerance test		0wk	No
Secondary	Blood glucose change with meal tolerance test		4wk	No
Secondary	Insulin and C-peptide changes with meal tolerance test		0, 4 wk	No
Secondary	Fasting blood glucose		0, 4 wk	No
Secondary	Insulin		0, 4wk	No
Secondary	C-peptide		0, 4wk	No
Secondary	Glycated albumin		0, 4wk	No
Secondary	High sensitivity C-reactive protein		0, 4wk	No
Secondary	Oxidized low-density lipoprotein		0, 4wk	No
Secondary	Malondialdehyde		0, 4wk	No
Secondary	Lipid profile (triglyceride, total cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, high-density lipoprotein cholesterol)		0, 4wk	No